minocycline hydrochloride in reducing chemotherapy induced depression and anxiety in patients with stage i-iii breast cancer

Conditions: Anxiety Disorder; Depression; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this randomized clinical trial studies how well minocycline hydrochloride works in reducing chemotherapy induced depression and anxiety in patients with stage i-iii breast cancer. minocycline hydrochloride may prevent changes in memory and thinking and improve the quality of life of breast cancer patients receiving chemotherapy.

primary objectives: i. to evaluate anxiety and depression in women with stages i-iii breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy randomized to receive either minocycline (minocycline hydrochloride) or placebo. ii. to evaluate markers of neuro-inflammation as assessed by blood based inflammatory cytokines and c11-choline positron emission tomography (pet) in women with stages i-iii breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy randomized to receive either minocycline or placebo. outline: patients are randomized to 1 of 2 arms. arm i: beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride orally (po) twice daily (bid) for 9 weeks. arm ii: beginning 1 week prior to chemotherapy, patients receive placebo po bid for 9 weeks. after completion of study treatment, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * women diagnosed with breast cancer stages i-iii initiating first line adjuvant or neoadjuvant doxorubicin hydrochloride (dox) chemotherapy * postmenopausal defined as amenorrhea \> 12 months or follicle stimulating hormone (fsh) and estradiol in institutional postmenopausal range * ability to understand english and read and write at the 8th grade level and give a written informed consent document * for additional cohort, women with breast cancer stages i-iii who currently on or within 18 months of completing first line adjuvant or neoadjuvant dox chemotherapy or other chemotherapy for breast cancer. exclusion criteria: * rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia * concurrent other malignancy or metastatic malignancy of any kind * reported diagnosis of major depression or anxiety disorder prior to breast cancer (bc) diagnosis * currently prescribed psychotropic medications including anti-depressants * known bleeding disorders * history of diabetes mellitus, heart disease or stroke * current use of warfarin or other anticoagulants * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements * pregnant or nursing women * concurrent use of daily full dose aspirin (\>= 325 mg/day), nonsteroidal anti-inflammatory drugs (nsaids) or nsaid-containing products or steroids; one month washout period is required prior to randomization * unable to give informed consent * tetracycline allergy * any contraindication to magnetic resonance imaging (mri)/pet examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia; (however, this portion is optional and if patient is otherwise eligible, can enroll in study without participating in imaging study)

Keywords: breast cancer